Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection

NCT00547495 | Completed Phase 3

• 2 other identifiers: 5139H6D-MC-LVDI
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 1

Brief Summary

Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.

Conditions

Impotence

Outcome Measures

Primary Outcomes (1)

• Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary

  12 weeks

Secondary Outcomes (1)

• Change from baseline to endpoint of various questions from the IIEF and SEP diary

  12 weeks

Study Arms (4)

1

PLACEBO COMPARATOR

Placebo tablet

Drug: placebo

2

ACTIVE COMPARATOR

5 mg tadalafil

Drug: tadalafil

3

ACTIVE COMPARATOR

10 mg tadalafil

Drug: tadalafil

4

ACTIVE COMPARATOR

20 mg tadalafil

Drug: tadalafil

Interventions

tadalafil DRUG

5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks

Also known as: LY450190, Cialis, IC351

2

placebo DRUG

placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks

1

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• months history of erectile dysfunction (ED)
• Anticipate a monogamous relationship with a female sexual partner
• Be able to make minimum required sexual intercourse attempts
• Abstain from using any other ED treatment

You may not qualify if:

• Other primary sexual disorders
• History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
• History of penile implant or clinically significant penile deformity.
• Nitrate use
• Certain heart problems

Sponsors & Collaborators

• Eli Lilly and Company: lead
• ICOS Corporation: collaborator

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sapporo, Hokkaido, Japan

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 22, 2007
• Study Start: March 1, 2004
• Study Completion: November 1, 2004
• Last Updated: October 22, 2007

Record last verified: 2007-10

Locations

JP (1)